AUTH/3010/1/18: Daiichi-Sankyo ruled in breach for omitting key SPC warning in Lixiana (edoxaban) promotional guides; corrective statement and recovery required

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Key facts

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Case	AUTH/3010/1/18
Parties	Bristol-Myers Squibb Pharmaceuticals and Pfizer v Daiichi-Sankyo UK Ltd
Medicine	Lixiana (edoxaban)
Therapy area	Anticoagulation / NVAF (prevention of stroke and systemic embolism)
Core issue	Omission from body text of SPC Section 4.4 warning about decreasing efficacy trend with increasing creatinine clearance; “should only be used” in NVAF patients with high CrCl after careful evaluation
Materials	Initiation Information Guide (EDX/16/0171); Practical Guide (EDX/15/0091(4))
Applicable Code year	2016
Complaint received	12 January 2018
Appeal Board consideration	13 September 2018; 17 October 2018
Undertaking received	3 October 2018
Corrective statement issued	14 December 2018
Breaches (final)	Clause(s) 2; 7.2; 7.10; 9.1
No breach (final)	Clause(s) 2; 7.9; 9.1; 26.1; 26.2 (Twitter element – out of scope on appeal)
Sanctions	Corrective statement; Advertisement; Recovery of items; Undertaking

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

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Bristol-Myers Squibb and Pfizer (the Alliance) complained about Daiichi-Sankyo’s promotion of Lixiana (edoxaban), a DOAC for NVAF.
The Alliance alleged a consistent omission in promotional materials of an SPC Section 4.4 warning: in NVAF, a trend towards decreasing efficacy with increasing creatinine clearance; therefore edoxaban should only be used in patients with NVAF and high creatinine clearance after careful evaluation of thromboembolic and bleeding risk.
Two prescriber booklets were highlighted:
- “Initiation Information Guide” (EDX/16/0171, 6 pages) designed to help prescribers initiate Lixiana appropriately.
- “Practical Guide” (EDX/15/0091(4), 19 pages) for prescribers on use of Lixiana, including efficacy/safety and special populations.
Daiichi-Sankyo argued the warning appeared in the prescribing information included with the materials and that the body text did not need to repeat it; it also argued the warning related to patients with normal renal function and did not require dose adjustment.
The Panel and Appeal Board considered that, given the nature of the warning and patient safety implications, it needed to appear prominently in the body of the materials; relying on prescribing information at the back was inadequate.
A separate complaint concerned Twitter use of “#safeplicity”. The Panel initially ruled breaches for two agency tweets, but the Appeal Board found the tweets were not within the scope of the ABPI Code (no specific reference to UK availability/use) and ruled no breach for those clauses on appeal.

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Outcome

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Breach found for the two prescriber guides for omission of the SPC warning in the body text.
Breaches upheld on appeal for the prescriber guides.
No breach ultimately (on appeal) for the Twitter-related clauses because the matter was found not to fall within the scope of the ABPI Code.

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